PremiumHyderabad-based Bharat Biotech shared complete data of all research studies conducted for Covaxin so far, adding that the final Phase III analysis data will be released soon.
As per a company statement, it has shared complete data for Phase I pre-clinical trials and Phase II clinical trials, along with partial data for Phase III clinical trials.
Company officials informed that all research data for Covaxin has been thoroughly scrutinised by the regulators in India. Bharat Biotech has published nine research studies on its coronavirus vaccine over the span of 12 months in five globally reputed peer-reviewed journals.
In its statement, Bharat Biotech claimed that Covaxin is the only product to have published any data from human clinical trials in India, and have efficacy data for Indian population. The vaccine manufacturer further said that Covaxin is the only Covid vaccine in the country to have published data on most emerging variants of the virus.
Sharing details about the published data, Bharat Biotech mentioned that among its Phase I trials, efficacy study in hamsters was published in CellPress, followed efficacy study in primates was published in Nature Communications. The preclinical and immunogenicity study was published in CellPress.
Data from both Phase I and II trials for Covaxin, done to assess a vaccine's safety, immune response and to determine right dosage and to assess the safety and the ability of the vaccine to generate an immune response, respectively, were published in Lancet-Infectious Diseases journal.
Studies on neutralisation of Alpha variant (B.1.1.7), Beta variant (B.1.351) and the Delta variant (B.1.617.2), as well as B.1.617 and B.1.1.28 variants were published in peer-reviewed journals bioRxiv, Clinical Infectious Diseases, and Journal of Travel Medicine.
"The study on the neutralisation of Beta and Delta variants (B.1.351 and B.1.617.2, respectively) and the study on B1.1.28 variant, at Journal of Travel Medicine, while the studies on B.1.617 variant and Alpha variant (B.1.1.7) are published at Clinical Infectious Disease and Journal of Travel Medicine, respectively," the pharma major said.
Bharat Biotech further stated that the Phase III final analysis data will also be published soon.
"Final analysis requires efficacy and 2 months' safety follow-up data on all subjects. This is CDSCO and USFDA," the company said. "The final analysis will be submitted CDSCO, followed by submissions to peer-reviewed journals and and media dissemination."
The statement from Bharat Biotech came a day after US Food and Drug Administration (USFDA) rejected its proposal for an emergency use authorization (EUA) of Covaxin, delaying the company’s vaccine launch in that country. Following USFDA's denial, Ocugen, Bharat Biotech's US partner, said the company will now seek a full approval for Covaxin.
Covaxin is the India's first indigenous Covid vaccine, and has been part of the nation's vaccination drive since it began on January 16 along with Serum Institute's Covishield.
The two-dose vaccine is developed using Whole-Virion Inactivated Vero Cell derived platform technology. As per information shared by Bharat Biotech, a total of 25,800 subjects have been enrolled and randomised in a 1:1 ratio to receive the vaccine and control in a event-driven, randomised, double-blind, placebo-controlled, multicentre phase 3 study for Covaxin.
